NCT03924011: LABRA

Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy

Completed NA Last updated 1 September 2021

What this trial tests

NA trial testing Photobiomodulation therapy (PBMT) in Radiodermatitis in 71 participants. Completed in 1 June 2021.

Timeline

1 July 2020

Primary endpoint
1 March 2021

1 June 2021

Quick facts

Lead sponsor	Hasselt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	71
Start date	1 July 2020
Primary completion	1 March 2021
Estimated completion	1 June 2021
Sites	2 locations across Belgium

Drugs / interventions tested

• Photobiomodulation therapy (PBMT)
• Sham laser

Conditions studied

• Radiodermatitis — all drugs for Radiodermatitis →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hasselt University

Who can join

18 and older, female only, with Radiodermatitis or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.

Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.

Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.

The results of this project will support the implementation of PBMT into the standard RD skincare program.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Photobiomodulation therapy for the prevention of acute radiation dermatitis in breast cancer patients undergoing hypofractioned whole-breast irradiation (LABRA trial).
   Robijns J, Lodewijckx J, Puts S, Vanmechelen S, et al · · 2022 · cited 13× · PMID 34481420 · DOI 10.1002/lsm.23475